MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. NEURO TRAY WITH SYRINGE; NEUROLOGICAL TRAY

Model Number	SPEC0070
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Md was beginning the set up of a patient's shoulder injection when she noticed that the syringe used to draw up lidocaine was cracked.The same md had the same thing happen a week prior while setting up another procedure.Another md at a nearby facility also had this happen to her with the same kit.The crack was not identified in this instance and the lidocaine shot across the room.In this event, the reporter of this event has spoken to the vendor and the vendor came to pick up the syringe and to take a look at it last week.

• Brand Name: NEURO TRAY WITH SYRINGE
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 8054665
• Report Number: 8054665
• Device Sequence Number: 1654310
• Product Code: OJG
• UDI-Device Identifier: 10884389517918
• UDI-Public: (01)10884389517918
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018
• Report Date (Section F): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SPEC0070
• Device Catalogue Number: SPEC0070
• Device Lot Number: 2018072450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/02/2018